Assured Pregnancy Test Sensitivity

Assured Pregnancy Test sensitivity is 25 mIU/ml. This means that when one milliliter of your urine contains 25 milli-International-Units of the hCG pregnancy hormone, you are most likely pregnant. So, for most women, the Assured Pregnancy Test will do the job.

Assured Pregnancy Test Sensitivity

We’ve already given you the quick answer to your question about Assured Pregnancy Test sensitivity. Continue reading to learn about what sensitivity means regarding your pregnancy test.

What is sensitivity?

Many prospective moms want to get the best results from their home pregnancy test. For this reason, manufacturers readily tout that their tests are “More than 99% accurate” and then put an asterisk (*) next to that claim.

You see, practically every test on the market is 99% accurate from the day of your missed period.

Naturally, you don’t want to wait until the day after your expected menstrual period (EMP) to find out.

That’s when things get complicated.

You can use your pregnancy test early, but that will affect the accuracy of your result.

Some tests provide more reliable results than others while testing early.

According to the FDA, for the Assured Pregnancy Test, the cutoff for a positive test is 25 mIU/ml.

FDA Links for Assured Pregnancy Test Sensitivity

You can view documents published by the U.S. Food and Drug Administration that discuss Assured Pregnancy Test sensitivity:

IVD Over the Counter (OTC) record K123703 and corresponding
510(K) Premarket Notification information

IVD Over the Counter (OTC) record K043443 and corresponding
510(K) Premarket Notification information

How do I measure Assured Pregnancy Test sensitivity?

Like most pregnancy tests, the Assured Pregnancy Test packaging and directions do not tell you the sensitivity of the test.

Finding out for yourself is difficult because testing for sensitivity requires lab equipment, many test subjects, and a controlled environment.

CPG Health has done the legwork for you.

As a matter of fact, CPG Health has worked with the distributor of the Assured Pregnancy Test to find out the test’s sensitivity rating.

Drum roll, please!

Assured Pregnancy Test sensitivity is 25 mIU/ml.

This means that when one milliliter of your urine contains 25 milli-International-Units of the HCG pregnancy hormone, you are most likely pregnant.

So, for most women, the Assured Pregnancy Test will do the job.

When does my HCG level reach 25 mIU/mL?

Most pregnant women have an hCG level of 25 mIU/mL 11 days past ovulation.

Of course, you can try to use the test early, but you can’t expect to get a reliable result. If you do this, be sure to have another test on hand to use on the day of your expected period.

More about HCG levels

Your body produces human chorionic gonadotropin (HCG) after implantation.

When does implantation occur?

Implantation normally occurs around the 9th day after ovulation. The general range is between 6 and 12 days.

Generally speaking, the 9th day after ovulation is about 5 days before your missed period.

Since some women receive positive results with the Assured Pregnancy Test sensitivity 11 dpo, this could mean that some pregnant women can get an accurate result as early as three days before their EMP.

Can I get better results with an early results test?

Some pregnancy tests are more sensitive than the Assured Pregnancy Test. Most of the time, packagers will label these tests as “Early Result.” They have sensitivities as low as 10 mIU/ml and claim that you can test four or five days before your expected period (which is equivalent to testing five or six days early).

Assured Pregnancy Test Sensitivity 2018

The Assured Pregnancy Test has been on the market for many years. The technology and materials used to make the test have stayed the same. For this reason, Assured Pregnancy Test sensitivity 2021 is the same as Assured Pregnancy Test sensitivity 2018.

The pregnancy test that’s marketed as the Assured Pregnancy Test was approved by the FDA in 2005.

According to documents filed with the FDA, test results for the Assured Pregnancy Test are as follows:

  • Fourteen (14) out of 15 samples (98.8%) at 25 mIU/ml HCG tested positive.
  • All results (100%) below 18.75 mIU/ml HCG tested negative.

When the concentration of the HCG pregnancy hormone in your urine matches or exceeds 25 mIU/ml, the Assured Pregnancy Test will give you a positive result.

Lab test results filed by the device’s manufacture indicate that the test will not reliably produce a positive test result when you have lower concentrations of hCG.

In other words, if you test early for pregnancy, you should always repeat your pregnancy test on the first day of your EMP. Before then, you might not have enough hCG in your urine before then to trigger a positive result.

Learn More about Assured Pregnancy Test sensitivity

The United States Food and Drug Administration lists the Assured Pregnancy Test as the “Greenbrier International Inc. Assured Pregnancy Test.”

Greenbrier International is the product’s distributor.

Guangzhou Wondfo Biotech Co., Ltd. manufactures the Assured Pregnancy Test.

The registered name for Assured Pregnancy Test is “ONE STEP HCG URINE PREGNANCY TEST.”

Read more about the Assured Pregnancy Test at FDA.Gov.

Go farther with CPG Health

Check additional resources hosted by CPG Health.

    CPG Health

    Pregnancy Test Index